ISPE Congress on Innovation
Pre-Meeting for PQLI Workshop - Introduction to ICH
Wednesday 9 April 2008
Seminar Leaders:
Bruce Davis, AstraZeneca, UK
Gert Mølgaard, NNE Pharmaplan, Denmark
This half-day session acts as a stand-alone introduction to ICH Guidance and as an accelerator to for the following 2 days.
Beyond an overview and introduction, the session will identify the perspectives of Assessors and Inspectors and outline essential background to the PQLI initiative.
- Up to date information on current ICH Guidelines, in particular Q8, Q9 and Q10
- Perspectives from regulators in all 3 ICH Regions (Europe, USA, and Japan)
- An essential background to the objectives and considerations of PQLI
Agenda:
| 13.30 – 13.40 | Welcome and Introduction Bruce Davis, Astra Zeneca, UK |
| 13.40 – 14.20 | Introduction to ICH and the way ICH works Chuck Hoiberg, Pfizer, USA • ICH Goals and Objectives • Membership • ICH Process • ICH Outputs |
| 14.20 – 15.00 | Overview of the ICH Guidelines Chris Potter, Consultant, UK • A brief general overview of ICH Quality topics • A view of its successes and a few issues • ICH Vision and Background to the current Quality initiatives particularly Q8, Q9 and Q10 • Status and challenges for Industry and Regulators |
| 15.00 – 15.20 | Coffee Break |
| 15.20 – 16.05 | ICH Implementation Work Groups and ICH Q8/Q9/Q10 Guidelines from an Assessors’ Perspective • Jean-Louis Robert, Laboratoire National de Santé, Luxembourg • Moheb Nasr, FDA, USA • Yukio Hiyama, MHLW, Japan |
| 16.05 – 16.50 | ICH Implementation Work Groups and ICH Q8/Q9/Q10 Guidelines from an Inspectors’ perspective • Jacques Morénas, AFSSAPS and Chair of PIC/S, France • Joe Famulare, FDA, USA |
| 16.50 – 17.00 | Wrap-up and lead into PQLI and Regulatory “Hot Topics” Round Tables Bruce Davis, AstraZeneca, UK |